Project Manager, Large Molecule ExM Technology

Kelly Science, Engineering, Technology & Telecom; United States; Remote; USD 100,000 - 175,000; Full time

Job summary

A leading company in the biopharmaceutical sector seeks a Project Manager for Large Molecule ExM Technology, focusing on overseeing drug substance processes and project management within a global network. Candidates should possess a strong background in biochemistry and substantial experience in project management and supplier development, fostering innovation and efficiency.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 10+ years of relevant experience in drug substance development.
• 4+ years in LM process development roles.
• Experience in supplier management and relationship building.

Responsibilities

• Manage LM drug substance portfolio within global CMO network.
• Lead supplier technical management and process development.
• Ensure project timelines and deliverables are met across teams.

Skills

Communication

Project Management

Strategic Thinking

Technical Acumen

Team Leadership

Education

Bachelor's/Master’s in Biochemistry, Biochemical Engineering, or comparable

Tools

Microsoft Project

Microsoft PowerPoint

Job description

Project Manager, Large Molecule ExM Technology

Project Manager, Large Molecule ExM Technology

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Location: Remote (Must be East Coast or Central Time Zone)

Travel: 15-30%

The global External Manufacturing Technology Group is a fast-growing area of the manufacturing network tasked with ensuring reliable, safe, and compliant manufacturing of drug substance and drug products. Specifically, this group manages tech transfer projects from R&D and inline nodes, develops or continuously innovates processes, and manages supply issues including troubleshooting. The technical vertical External Manufacturing is the steward of the processes and is responsible for end-to-end project management of R&D and inline projects. The client has both large and small molecule external networks, and this opportunity is covering the Large Molecule drug substance as the primary focus.

Responsibilities:

• The role is pivotal in the management of the LM drug substance portfolio within the client's global CMO (Contract Manufacturing Organizations) network, including responsibilities in both the commercial and pre-approval space. As overall leader or technical leader, you will be focusing on leveraging external suppliers for LM drug substance process development, scale-up, full-scale production, and commercial lifecycle management. You will be part of the External Manufacturing Technology Management Group and will be responsible for a portfolio of LM drug substance projects and/or supply nodes with a focus on in-line supply. The potential project types include sourcing, technical transfer, R&D, process improvement & innovation, and troubleshooting.
• In addition, spot audits and sourcing support on behalf of other team members will be required at times.
• The role is global and is a perfect fit for individuals with a strong drive for excellence and achieving tangible business results. Critical skills include strategic thinking and proactive project management with business and technical acumen, verbal communication, and electronic communication. The individual needs to be able to act independently and travel as needed.
• In this position, the focus will be placed on the technical leadership during all aspects of drug substance sourcing, process development, commercialization, and subsequent lifecycle management. Once a supplier is selected, the individual will then be fully responsible for end-to-end execution of the project as the leader of execution managing both the internal drug product customers and the external supplier during the technical transfer or process development. Once the technical transfer, validation, and regulatory approval for a sourcing project is completed and for assignments to in-line supply, leadership of the client’s Supplier Technical Management program will be expected. In addition, each member of the technology team will contribute to generating innovation and systems improvements as appropriate.
• The individual will be expected to partner with stakeholders within our client’s External Manufacturing & Global Procurement organization as well as other functional departments to complete global sourcing & development projects. Here, the individual will define the requested services, including generating technical packages, lead technical due diligence for supplier selection, and verify that aspects of supplier selection are considered appropriately, including assurance of supply, quality, service, cost, and innovation.
• At all times, the individual must be adept at managing customer relationships, internal our client’s company, and external suppliers.
• Supplier Technical Management will be conducted to ensure the on-time and full delivery of drug substance to our client. The individual will be expected to manage a defined set of suppliers and act as steward for select drug substances and:
• Lead cross-functional meetings with the external suppliers and the company's internal personnel to monitor the technical aspects of the relationship, including tracking all changes, deviations, and improvement projects.
• Lead the process change team inside of our client, working closely with our internal or external formulation facilities, regulatory, and quality to execute changes at the supplier.
• Follow up on deviations and ensure they are resolved quickly and appropriately.
• Ensure appropriate knowledge management of drug substance technology.
• Develop and pursue innovation projects with the supplier to improve process efficiency and reduce Cost of Goods (COGs).
• For R&D projects, guide process development at the supplier.
• Leverage appropriate software systems, including for supplier communication and change control.
• Importantly, for all assignments, the Project Manager must:
• Provide strong leadership and business acumen for project management and lead cross-functional team members effectively.
• Display our company's leadership behaviors and demonstrate high emotional intelligence.
• Create overall project schedules with Microsoft Project, including input from cross-functional partners (regulatory, formulation, supply chain, quality, procurement, R&D) and ensure they are appropriate for the project delivering end-to-end outcomes.
• Work closely with external suppliers to proactively develop or assess the manufacturing process, evaluate processing equipment, and limit risks during scale-up, transfer, or process changes.
• Present status updates via Microsoft PowerPoint in the relevant governance forum meetings.
• As required, the individual will assist communications with the suppliers during troubleshooting or visit facilities to conduct due diligence.

Education Required:

• Bachelor's/Master’s degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering, or comparable

Required Experience or Skills:

• Minimum 10 yrs. of relevant experience
• The candidate must have experience in the development of a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA, etc.) and a demonstrated high level of technical capability.
• A minimum of 4 years spent in LM process development roles.
• A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing, process development & commercialization, tech transfer, manufacturing process troubleshooting, and supply of biotechnology products.
• Strong Leadership attributes, including a global mindset.
• Demonstrated ability to lead cross-functional teams with an end-to-end supply chain view.
• Ability to collaborate across functions and geographies and support global activities.
• Strong interpersonal and communication skills
• Ability to maintain strong working relationships with technical, quality, and operations leaders in the internal and external network.
• Ability to use Microsoft Project and the Microsoft suite of applications.

Preferred Experience and Skills:

• PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering, or comparable with a minimum of 7 yrs. of relevant experience.
• Understanding and experience in process scale-up for LM drug substances.
• Expertise in troubleshooting of upstream and downstream operations.
• Demonstrated track record of managing technical projects in global CMOs.
• Experience in due diligence audits of CMOs.
• Working knowledge of Regulatory strategy and execution in EU and US (FDA and/or USDA).
• Six Sigma and/or Project Management Professional (PMP) certification preferred.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management, Science, and Information Technology

• Industries

  Staffing and Recruiting and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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